Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 0.05%
Ocular Inflammation & Pain
Initate 24 hours postop: Instill 1 gtt in conjunctival sac of affected eye(s) q6hr for 2 weeks, then q12hr for1 week, then taper and discontinue
Uveitis
Indicated for treatment of endogenous anterior uveiti
Instill 1 ftt into conjunctival sac to affected eye(s) q6hr for 14 days and then taper dose downward as clinically indicated
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Increased IOP
Anterior chamber inflammation
Corneal edema
Conjunctival edema
Blepharitis
Cataract
Optic nerve damage
Abnormal healing (after surgery)
Local irritation
Punctate keratitis
Hyperemia
Punctate keratitis
Decreased visual acuity
Eye pain
Photophobia
Postmarketing Reports
Elevated intraocular pressure
Posterior subcapsular cataract formation
Secondary ocular infection
Perforation of the globe
Warnings
Contraindications
Most active viral diseases of cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures
Cautions
Not for intraocular administration
Prolonged use of corticosteroids may result in glaucoma with damage to optic nerve, defects in visual acuity and fields of vision; steroids should be used with caution in presence of glaucoma; monitor intraocular pressure if product used for ≥10 days
May increase risk of posterior subcapsular cataract formation
The use of steroids after cataract surgery may delay healing and increase incidence of bleb formation; perforations, associated with thinning of cornea or sclera, may occur; initial prescription and renewal of medication order beyond 28 days should be made by a physician only after examination of patient with aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining
Employment of corticosteroid medication in treatment of patients with history of herpes simplex requires great caution; use of ocular steroids may prolong course and may exacerbate severity of many viral infections of the eye (including herpes simplex)
Prolonged use of corticosteroids may suppress host response and thus increase hazard of secondary ocular infections; in acute purulent conditions, steroids may mask infection or enhance existing infection; if signs and symptoms fail to improve after 2 days, patient should be re-evaluated
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where steroid has been used or is in use; fungal culture should be taken when appropriate
The drug should not be instilled while wearing contact lenses; remove contact lenses prior to instillation; the preservative may be absorbed by soft contact lenses; lenses may be reinserted after 10 minutes following administration of this drug
Pregnancy & Lactation
Pregnancy
Shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day; the no- observed-effect-level (NOEL) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females
Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic; at 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females
It is difficult to extrapolate these doses of difluprednate to maximum daily human dose of this drug, since this drug is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies; however, since use of this drug during human pregnancy has not been evaluated and cannot rule out the possibility of harm, this drug should be used during pregnancy only if potential benefit justifies potential risk to embryo or fetus
Lactation
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
Exercise caution when therapy administered to a nursing woman
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antiinflammatory corticosteroid; inhibits inflammatory response including capillary dilation, edema, leukocyte migration, and scar formation
Absorption
Absorption: Negligible absorption
Metabolism: Undergoes deacetylation to active metabolite
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| difluprednate ophthalmic (eye) - | 0.05 % drops |  | |
| Durezol ophthalmic (eye) - | 0.05 % drops |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
difluprednate ophthalmic (eye)
DIFLUPREDNATE - OPHTHALMIC
(DYE-floo-PRED-nate)
COMMON BRAND NAME(S): Durezol
USES: This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.
HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.If you are wearing contact lenses, remove them before using eye drops. Wait at least 10 minutes before replacing your contact lenses.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop.Do not rinse the dropper. Replace the dropper cap after each use.Use this medication exactly as directed by your doctor. Your doctor may direct you to use this medication more often at the beginning of treatment and then reduce your dose gradually. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Continue using it for the full time prescribed.If you are using another kind of eye medication (for example, drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.Tell your doctor if your condition lasts or does not improve.
SIDE EFFECTS: Temporary blurred vision may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Use of this medication for prolonged or repeated periods may result in a new fungal infection. Do not use this medication for longer than prescribed.Tell your doctor right away if you have any serious side effects, including: new or increased eye pain/swelling/discharge/redness, eye pain/discomfort in bright light, vision changes.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using difluprednate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or past eye infection (including viral infections such as herpes simplex keratitis), cataracts, glaucoma.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you can do it safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if difluprednate passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as intraocular pressure) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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